NCT07066020

Telehealth Exercise Boosts Sleep and Reduces Parental Stress in Autism

A Telehealth-Delivered Physical Activity Intervention Improves Sleep and Reduces Parental Stress in Children With Autism Spectrum Disorder: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Hunan Normal University · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This study aims to test whether a physical activity program delivered through telehealth can help improve sleep quality in children with autism spectrum disorder (ASD) and reduce stress and improve well-being in their parents. Children in the study will wear a small device (an accelerometer) to measure their physical activity levels and sleep. Parents will answer questionnaires about their child's sleep habits, behavior, and social skills, as well as their own sleep, stress levels, and parenting experience. The program will be delivered remotely, allowing families to participate from their homes. It includes guided physical activities, family-based exercises, and regular telehealth support from professionals. The goal is to find out if this type of remote support can help both children with autism and their caregivers in daily life.

Conditions

• Autism Spectrum Disorder (ASD
• Sleep Disturbances in Children
• Parental Stress

Interventions

Type	Name	Description
BEHAVIORAL	Telehealth-delivered Physical Activity Program for Children with ASD	This is a 16-week, theory-informed (Social Cognitive Theory and Self-Determination Theory) caregiver-mediated physical activity intervention delivered remotely via videoconference to caregivers of children with autism spectrum disorder. Caregivers participate in 24 synchronous group sessions delivered twice weekly during weeks 1 to 8 and once weekly during weeks 9 to 16; the final session focuses on maintenance. Sessions are delivered in closed cohorts aligned with the randomized classroom clusters and cover individualized activity planning, collaborative goal setting, behavior change support, and safety education. Caregivers are instructed to facilitate at least 3 structured home-based physical activity sessions per week for their child and submit biweekly activity logs. Interventionists review logs and conduct two brief individualized telephone consultations per family to provide tailored feedback and address implementation barriers. Each family receives standardized written material
BEHAVIORAL	In-Person Supervised Physical Activity Program	This is a 16-week, structured, in-person physical activity intervention for children with ASD. The program consists of three 40-minute sessions per week delivered on-site at a partner school by certified physical education instructors. The curriculum is manualized and includes an Individualized Motor Protocol, Structured Group Sessions, and Behavior Change Support. Instructors provide direct, hands-on correction and feedback during sessions, adjusting task difficulty in real-time to match each child's individual capabilities and needs.
OTHER	General Health Education Materials	This is a minimal intervention control. Participants in this group do not receive a structured or guided physical activity program. At the beginning of the study, caregivers are provided with a one-time, webinar-style session on general pediatric health topics (e.g., nutrition, sleep hygiene) and an exercise guidance manual. These materials are for optional, independent use by the caregivers, and no active monitoring or follow-up is provided by the research team regarding their use.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-01
• Completion: 2024-11-01
• First posted: 2025-07-15
• Last updated: 2026-03-03

Locations

1 site across 1 country: China